The following data is part of a premarket notification filed by Fujirebio Diagnostics, Inc. with the FDA for Lumipulse G He4 Immunoreaction Cartridges, Lumipulse G He4 Calibrators.
Device ID | K151378 |
510k Number | K151378 |
Device Name: | Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators |
Classification | Test, Epithelial Ovarian Tumor Associated Antigen (he4) |
Applicant | Fujirebio Diagnostics, Inc. 201 Great Valley Parkway Malvern, PA 19355 |
Contact | Diana Dickson |
Correspondent | Stacey Dolan Fujirebio Diagnostics, Inc. 201 Great Valley Parkway Malvern, PA 19355 |
Product Code | OIU |
CFR Regulation Number | 866.6010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-05-22 |
Decision Date | 2015-11-24 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04987270234181 | K151378 | 000 |
04987270234174 | K151378 | 000 |